MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II COLONOVIDEOSCOPE

Model Number	PCF-H180AL
Medical Device Problem Codes	Break (1069); Crack (1135); Fluid/Blood Leak (1250); Dent in Material (2526)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the control knob leaks.There are deep dents in the plastic cover.The a-rubber glue is cracked.There are edge chip/scratches on the ob lens.The lg lens has 2 cracks.The image has one white dot in zone 2.The camera switch has 2 cuts.The insertion tube is non-olympus.The lg tube is non-olympus.The cover glass is loose.There is a broken angle wire causing no "up" angulation.The control knob has low tension and play.The labels are peeling.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during a procedure using a evis exera ii colonovideoscope, the angulation control knob was broken.The is no patient impact related to this occurrence.
Additional Manufacturer Narrative
This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: the definitive cause of the user's experience could not be determined.Based on the available information the following are the presumed possible causes: it is possible that excessive force could have been applied causing the angulation wire to break.More than 10 years have past since the device was manufactured, it is possible there is age related deterioration.
Additional Manufacturer Narrative
Upon further review this has been determined to be not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to a death or serious injury should it recur.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11123231
• Report Number: 8010047-2021-00941
• Device Sequence Number: 14604101
• Product Code: FDF
• UDI-Device Identifier: 04953170339899
• UDI-Public: 04953170339899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PCF-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 03/09/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/02/2021; 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1